Unapproved CBD Products with Unsubstantiated Claims

Cannabidiol medications are no doubt changing the face of pharmaceutical and herbal medicine cultivation and production. Cannabis medications show unprecedented promise as a new treatment for nausea, eating disorders, chronic pain relief and seizure control, possibly even treating anxiety and depression.

Approved, well-researched cannabis formulations — cultivated, produced and tested per PICS/GMP (or EU GMP) requirements — are one thing. These products have undergone clinical-research and quality testing to back up their safety, quality and efficacy claims.

The trouble is that vulnerable people — especially distressed parents and extremely ill patients — can be readily misled about the benefits of cannabis medications, including unapproved CBD-based pharmaceuticals and oils being marketed online….products neither FDA approved nor adequately researched, nor quality and safety tested. These can prove exceptionally risky to patients of all ages, yet alone to younger generations.

So, too, can investors in cannabis cultivation operations be misled, when they fail to fully understand the many cannabis cultivation challenges facing the industry.

Too many would-be-operators and investors are also under-informed about GACP and GMP requirements, and other quality controls, including the need to ensure your employees, facilities and workflow processes meet licence, security and regulatory requirements.

Scientists Views of CBD Medications – Safety, Quality and Efficacy

Few scientists doubt cannabis plant-based medications will prove efficacious for treating a number of conditions where existing treatments fail. However, robust data on the efficacy, safety and dosing of newer formulations with CBD or TCH APIs, simply isn’t available yet…with very few exceptions.

That’s why there are so few TGA or FDA approved medication formulations at this point in time.

That’s also the reason unapproved cannabis medicines are often difficult to attain, as well as being relatively expensive compared to approved drugs covered by public health benefits or insurance schemes.

These new formulations can also be potentially risky to public health. They can vary tremendously in safety and efficacy factors, such as variable API percentages when a manufacturer isn’t compliant with GACP/GMP.

Deceptive Certificates of Analysis (CoA or CofA) for Medicinal Cannabis

Cannabis Medication Cost Differences

The cost of unapproved cannabis medications compared to approved medications

Not being listed on the Pharmaceutical Benefits Scheme (PBS) — or the FDA approved medications lists — means unapproved medications can be relatively expensive to purchase, compared to currently approved treatments.

The process for applying for medicinal cannabis use can be daunting to patients and doctors alike (the Special Scheme Access process for medicinal cannabis is governed at the State Level).

But the ODC is also involved, and Doctors must have adequate training before they can prescribe medications containing cannabis.

Advertised CBD cannabis medication treatment claims — true or false?

Other than the short-list of currently FDA approved medications (above), evidence-based research remains sparse about the effectiveness of other CBD products and cannabis plant-based medications currently being studied

From an objective, scientific viewpoint, we still know very little, other:

cannabis medications are likely to have wide-ranging potential across a number of conditions and diseases, and

cannabis use by humans has occurred for social, medicinal, cultural and ‘spiritual’ for thousands of years

Rumors suggest that Shakespeare’s most inspired writings may have been influenced by his use of cannabis, a hotly debated discussion

No doubt many luminaries along the way have at least tried cannabis on one or more occasions, however, as up to 30% of the population in well-studied cultures have tried cannabis at least once in their lifetimes, with up to 1 in 10 people admitting to frequent or daily consumption

For the majority of currently available cannabis medicines — and widely-sold CBD-based products and beverages being marketed in the USA — we still lack robust, objective and scientific data. Placebo effects aside, this means current claims about the benefits of CBD-based products and medications are speculations, more than science.

Until evidence-based data from substantial clinical trials is gathered, analysed and published, CBD medicine claims are, at best, optimistic and unproven….and at worst, they are false and misleading. The FDA is cracking down.

Why is so little currently known about what CBD products can —- or cannot — accomplish for specific health conditions and patient populations?

The gaps in our knowledge about cannabis medications arise from many interactive factors. One dynamic involves a long history of cannabis bans, which thwarted cannabis research in many regions across the globe. There’s also been ongoing resistance to acknowledging the potential value of psychoactive medications in treating a variety of diseases — including the fear of making them worse.

Sadly, despite the plant showing promise as an herbal medicine resource, there also remains a great deal of stigma — and ill-informed stereotyping — about cannabis users and would-be patients.

Clinic Trials and Completion Dates (Targets): When will key cannabis studies be completed?

Several larger international studies are nearing their completion dates

Yet with countries staggered in cannabis legality approvals and research participation enrollments, there’s still a far way to go

The clinical research data will still need to be compiled and analyzed, and potentially confounding factors will need to be explored

Some early study findings are suggesting positive efficacy, some are revealing none; and others are showing a need to investigate toxicity on organs, such as liver toxicity/kidney damage

Factors which interact to result in TGA or FDA medication approval delays for cannabis medication include:

These dynamics mean we’re still a few years off from having solid data upon which regulatory authorities (the FDA in the USA, the TGA in Australia), can access to make an informed decision about the safety, quality and efficacy of emerging cannabis-derived medicines.

While robust clinical research studies into cannabis-derived medications will shed light on the efficacy and acceptable dosing ranges of these new medicines – including quantifying the risks of unwanted drug effects – companies in the USA are, sadly, marketing cannabis medications with numerous false claims.

Unsubstantiated medical benefit claims are inherently false. CEOs of cannabis companies who allow, and even encourage, employees to make unsubstantiated claims on social media pages and other channels — are getting FDA warning letters. This could signal a likelihood of licence suspensions and fines, or even criminal charges if patients end up being harmed.

Companies have been found targeting parents and children with cannabis ads that clearly have false claims in view of safety and efficacy. They are using unscrupulous marketing practices to sell their products, which have not yet been approved by regulatory authorities, and which often lack even basic testing to a standard the public expects (despite testing laws). And it would be highly unlikely any well-qualified medical practitioner, scientist or clinical researcher would make a statement about the safety and effectiveness of these medications for use by children who’s neurological systems are still in development — and which will be in development, for years to come.

Unregulated and untested products: Quality and Safety Issues

Not only are advertising claims for unapproved medications/CBD products FALSE:

Many unapproved products are the subject of public health/product quality concerns

There have been many incidents of a lack of safety testing and a lack of GACP/GMP/quality assurances in manufacturing practices

Documented concerns include variances in API percentages for CBD or THC and shelf-life instability (safety, quality and efficacy – the aim of good manufacturing practices).

Contaminants in medicinal products are dangerous. They could readily lead to serious inflammation and infections in already-vulnerable patients with immune-compromised systems, such as cancer treatment patients, patients with pneumonia, and those with other later stage diseases. This is why following good agricultural and collection practices (GAP/GAC or ‘GACP’ as it’s often called), and good manufacturing practices (GMP/EU GMP), is such a crucial component of public safety when it comes to medicines.

Despite a general laxity of drug-marketing guidelines in the USA, which allow pharmaceutical companies to advertise their medications directly to consumers (unlike the strict restrictions on drug advertising in Australia), there are still regulations in view of making unsubstantiated claims (false advertisements for medicines). In the latest of many similar news stories, a group in Florida has been advertising CBD medications and targeting parents of children with Autism, Asperger’s and ADHD.

Scientists who understand the effects of psychoactive ingredients on still-developing brains are appalled by their blatantly unsubstantiated claims, such as safety when used by children.

FDA Warning Letters, Consumer Protection Laws and Criminal Offences

False Claims about Medicinal Benefits of Cannabis Medication

Numerous USA suppliers of cannabis products and unapproved medications are making unsubstantiated claims about their products. Other companies are failing to sufficiently quality-test their products, or are using quality-testing certificates in deceptive manners to try to con the public into thinking their products are safe and effective. They often lack evidence of any kind to support their claims. Such advertising is against the law.”

Deceptive advertising (unsubstantiated) not only threatens the operator’s licences and operational sustainability (business stability), the CEOs/managers and even employees of these companies could incur direct liability should the public come to harms from product usage.

The regulators have been watching and warning letters sent. And the FDA is catching up with them.”

False advertisements for the effectiveness of cannabis-based pharmaceuticals and CBD products are also in breach of consumer protection laws

False marketing claims, combined with adverse effects and other health harms, could result in serious financial penalties and criminal charges (jail time).

Another issue of concern is fake medicines (counterfeit medications) making their way into consumer markets

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